• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH DUROM ACETABULAR COMPONENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER GMBH DUROM ACETABULAR COMPONENT Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problems Erosion (1750); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Medical product: metasul head; catalog#: unknown; lot#: unknown. Therapy date: (b)(6) 2020. The manufacturer did not receive devices or x-rays for review. Other source documents (surgical report) were provided. As no lot numbers were provided for the devices, the device history records could not be reviewed. While a cause for this specific event cannot be ascertained from the information provided, the common clinical presentation and the date of the original implantation suggest that this case is related to the issues for which zimmer implemented a notification in july 2008. Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. Zimmer¿s reference number of this file is (b)(4).
 
Event Description
Patient was implanted on the right side and underwent revision surgery due to wear, pain and femoral neck erosion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDUROM ACETABULAR COMPONENT
Type of DeviceDUROM ACETABULAR COMPONENT
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10152214
MDR Text Key195155820
Report Number0009613350-2020-00256
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Non-Healthcare Professional
Remedial Action Notification
Type of Report Initial
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number9613350-07/15/2008-001C

Patient Treatment Data
Date Received: 06/15/2020 Patient Sequence Number: 1
-
-